510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K082944 | Crystalsert Crystalens Delivery System | Bausch & Lomb Incorporated | MSS | Class I | |
| K082928 | Straight Fire Holmium Laser Fiber | Boston Scientific Corporation | GEX | Class II | |
| K082732 | Modification to: Capstone Spinal System | Medtronic Sofamor Danek USA Inc | MAX | Class II | |
| K082615 | Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone Void Filler Devices | Osteotech Inc | MQV | Class II | |
| K082402 | Osdx Hip Bmd System | Imaging Therapeutics, Inc. | KGI | Class II | |
| K082338 | Polybone Granule & Block | Kyung Won Medical Co., Ltd. | MQV | Class II | |
| K082258 | Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with and without Splash Visor | Crosstex International, Inc. | FXX | Class II | |
| K082051 | Cosman G4 Radiofrequency Generator, Model Rfg-4 | Boston Scientific Neuromodulation Corporation | GXD | Class II | |
| K081759 | Ncb Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking System, 3.5Mm Tivanium Ti-6Al-4V | Zimmer GmbH | HRS | Class II | |
| K081196 | Spinal USA Vbr System | Spinal USA | MAX | Class II | |
| K080793 | Firmgrip | Flexicath, Ltd. | FOZ | Class II | |
| K080581 | Vb Image Viewer | Olympus Medical Systems Corp. | JAK | Class II | |
| K082916 | Hrb-127-32 High Resolution Brain Coil | Invivo Corporation | MOS | Class II | |
| K082890 | Vnus Closurefast Intravascular Catheter, Models Cf7-7-60-2, Cf7-7-100-2 | Vnus Medical Technologies, Inc. | GEI | Class II | |
| K082856 | Carapaste Oral Wound Dressing | Mcgrath Pharmaceuticals, Inc. | OLR | Unclassified | |
| K082681 | Vacora Vacuum Assisted Biopsy System | C.R. Bard Inc | KNW | Class II | |
| K082666 | Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control, Power Cord, Wands | ArthroCare Corporation | GEI | Class II | |
| K082446 | Biomet Metal-on-Metal Hip Systems- Expanded Contraindications | Zimmer GmbH | KWA | Class III | |
| K082445 | Curative980 Diode Laser | Oroscience, Inc. | GEX | Class II | |
| K082398 | Encore Hip Stems with Ceramic Heads and Uhmwpe Liners | Encore Medical, LP | LZO | Class II | |
| K082336 | Xr-Express | New Mexico Software, Inc. | LLZ | Class II | |
| K082232 | Evis Md Plantium Blue | Ageless Beauty Corporation | GEX | Class II | |
| K082158 | Denseo Fairy | Xpdent Corp | EIH | Class II | |
| K082092 | Dispo-Bag Manual Resuscitator, Disposable Adjustable PEEP Valve, Disposable Fixed PEEP Valve | Galemed Corp. | BTM | Class II | |
| K082081 | Mako Surgical Corporation Unicondylar Knee Implant System III | Mako Surgical Corp. | HSX | Class II | |
| K082063 | Prelude Short Sheath Introducer | Merit Medical Systems, Inc. | DYB | Class II | |
| K081710 | Apogee and Perigee Systems with Pc Coated Intepro Lite | American Medical Systems, Inc. | OTP | Class III | |
| K081674 | Bindazyme Human Anti-Gliadin (Mgp), Igg Eia Kit; Bindazyme Human Anti-Gliadin (Mgp) Iga Eia Kit; (Iga or Igg) | The Binding Site | MST | Class II | |
| K081626 | Flowpicc Console | Teleflex Medical | OBJ | Class II | |
| K080919 | Nxstage Pureflow Sl | NxStage Medical Inc | FKR | Class II | |
| K080632 | Clear1-Day Hioxifilcon Daily Disposable Soft Contact Lens | Clearlab SG Pte, Ltd. | MVN | Class II | |
| K073582 | Vriicu System | Deep Breeze, Ltd. | OCR | Class II | |
| K072926 | Helontix Vent | Linde Gas Therapeutics | CBK | Class II | |
| K082828 | Suturtek 360 Degree Sternal Closure Device | Suturtek Incorporated | GAQ | Class II | |
| K082703 | Mrdh Bandage | Marine Polymer Technologies, Inc. | KMF | Class I | |
| K082684 | 4D Viewer Radiology, Model Uswp-100A | Toshiba America Medical Systems, In.C | LLZ | Class II | |
| K082543 | Sonocine Adjunctive Breast Ultrasound System (Abu), Model 100 | Sonocine, Inc. | IYO | Class II | |
| K082447 | Disposable Vinyl Examination Glove, Powder Free | Rich Mountain Medical Products, Inc. | LYZ | Class I | |
| K082213 | Gs III Fixture System | OSSTEM Implant Co., Ltd. | DZE | Class II | |
| K082012 | Cosman RF Injection Electrodes, Models Cu, Cur, Ccd, Tcd, Cp, Cr, Cn | Boston Scientific Neuromodulation Corporation | GXI | Class II | |
| K081793 | Philips Mp5 and Mp5t Intellivue Patient Monitors and Trx4841a Intellivue Telemetry System Transceiver | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | |
| K082959 | Patient Monitoring Cables for ECG, EKG, Spo2 and Blood Pressure Monitors | Unimed Medical Supplies Inc | DSA | Class II | |
| K082830 | Infx-8000H, Infinix-I | Toshiba America Medical Systems, In.C | JAA | Class II | |
| K082718 | Tempusic Patient Monitor | Remote Diagnostic Technologies Ltd. | DXH | Class II | |
| K082702 | Exactech Equinoxe Reverse Shoulder System+15mm Humeral Adapter Tray | Exactech, Inc. | PHX | Class II | |
| K082680 | Loci N-Terminal Pro-Brain Natriuretic Peptide Calibrator, Model Rc623 | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K082675 | Sta-R Evolution Automated Multi-Parametric Analyzer | Diagnostica Stago, Inc. | JPA | Class II | |
| K082653 | Centering Intraluminal Applicator | Varian Medical Systems, Inc. | JAQ | Class II | |
| K082350 | Pax-500 | Vatech Co., Ltd. | OAS | Class II | |
| K082332 | Nuvasive Spherx System | NuVasive Inc | NKB | Class II |